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Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
hyaluronic Acid + platelet-rich plasma
hyaluronic acid
platelet-rich plasma
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Knee pain for 4 months;
  • Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
  • Patients able to understand the study conditions and willing to participate for its entire duration;
  • Patients who signed written informed consent.

Exclusion criteria:

  • Severe knee osteoarthritis of grade 4;
  • Diabetes mellitus;
  • Rheumatoid arthritis;
  • Ongoing malignancies;
  • Certified allergic reactions towards the administered drugs ;
  • Malalignment of mechanical axis of the lower limb (varus > 10 °, valgus > 10 °);
  • Coagulopathies;
  • Severe cardiovascular diseases;
  • Ongoing infections;
  • Immunodepression;
  • Anticoagulants or anti-platelet agents;
  • Haemoglobin < 11 g/dl;
  • Platelet count < 150,000/mm^3
  • Drug addiction;
  • Alcoholism;
  • Psychiatric disease;
  • Pregnancy or breastfeeding.

Sites / Locations

  • U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
  • IRCCS Policlinico San Donato

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

hyaluronic acid + platelet-rich plasma

platelet-rich plasma

hyaluronic acid

Arm Description

Intra-articular injections of hyaluronic acid combined with platelet-rich plasma

Intra-articular injections of platelet-rich plasma

Intra-articular injections of hyaluronic acid

Outcomes

Primary Outcome Measures

WOMAC score
Comparison of WOMAC total score among three treatment arms

Secondary Outcome Measures

Full Information

First Posted
July 6, 2017
Last Updated
June 10, 2021
Sponsor
University of Milan
Collaborators
Regen Lab SA
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1. Study Identification

Unique Protocol Identification Number
NCT03211650
Brief Title
Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis
Official Title
Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
March 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
Collaborators
Regen Lab SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyaluronic acid + platelet-rich plasma
Arm Type
Experimental
Arm Description
Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
Arm Title
platelet-rich plasma
Arm Type
Active Comparator
Arm Description
Intra-articular injections of platelet-rich plasma
Arm Title
hyaluronic acid
Arm Type
Active Comparator
Arm Description
Intra-articular injections of hyaluronic acid
Intervention Type
Drug
Intervention Name(s)
hyaluronic Acid + platelet-rich plasma
Other Intervention Name(s)
Cellular Matrix/A-CP HA Kit
Intervention Description
Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid
Other Intervention Name(s)
ArthroVisc40
Intervention Description
Intra-articular injections of hyaluronic acid
Intervention Type
Drug
Intervention Name(s)
platelet-rich plasma
Other Intervention Name(s)
RegenKit-BCT-1
Intervention Description
Intra-articular injections of platelet-rich plasma
Primary Outcome Measure Information:
Title
WOMAC score
Description
Comparison of WOMAC total score among three treatment arms
Time Frame
6 months after the first intra-articular injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Knee pain for 4 months; Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3; Patients able to understand the study conditions and willing to participate for its entire duration; Patients who signed written informed consent. Exclusion criteria: Severe knee osteoarthritis of grade 4; Diabetes mellitus; Rheumatoid arthritis; Ongoing malignancies; Certified allergic reactions towards the administered drugs ; Malalignment of mechanical axis of the lower limb (varus > 10 °, valgus > 10 °); Coagulopathies; Severe cardiovascular diseases; Ongoing infections; Immunodepression; Anticoagulants or anti-platelet agents; Haemoglobin < 11 g/dl; Platelet count < 150,000/mm^3 Drug addiction; Alcoholism; Psychiatric disease; Pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Randelli, Professor
Organizational Affiliation
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
City
Milano
State/Province
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milan
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

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Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

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